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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

P/vP Properties

The biodegradation potential of the test substance was evaluated in accordance with OECD 301F guidelines and in compliance with GLP principles. The study included 4 test groups; test suspensions, inoculum blank, procedure control and toxicity control. The test substance concentration used was 23 mg/L (equivalent to 52 mg/L COD) and the concentration of the reference substance was 34 mg/L (equivalent to 56 mg/L of ThOD). Activated sludge was used as inoculum with a concentration of 30 mg/L suspended solids.  The total number of bacteria in the test system was 1.1xE7 CFU/L. The test was conducted for 28 days (in the dark and under sealed conditions) with a temperature of 22.0 °C - 22.9 °C (within 22 °C ± 10 °C).  The pH values were 7.28 - 7.42 (at the start of the test), and 7.20 - 7.26 (at the end of the test). The test satisfied all the validity criteria.

Under the conditions of the study, the percentage biodegradation of the test substance on Day 28 was determined to be 77.8 % (average of two replicates). Furthermore, since the test substance is a UVCB consisting of structurally similar chemicals, the 10-day window for ready biodegradability should not be applied to interpret the results of the test according to OECD guidance and the test substance is considered to be readily biodegradable.

 

B/vB Properties

Bioaccumulation is assessed using read-across from the structurally similar substance R04-5135. A read-across justification is provided in Section 13. Test material R04-5135 was tested in a bioaccumulation study in Cyprinus carpio at concentrations of 0.02, 0.1 and 1 mg/L. Steady-state BCF values were reported in the range of 17 to 492 at three different test substance concentrations. These results indicate that R04-5135 is not bioaccumulative.  R04-5135 is not considered readily biodegradable, whereas the target substance, 3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione is readily biodegradable. As degradation will result in less substance being available for bioaccumulation, it is considered that bioaccumulation assessments based on the more persistent source substance will be conservative in nature. Therefore, it can be concluded that 3-sec-[C15-18-(branched and linear)-alk-2-enyl]pyrrolidine-2,5-dione is not bioaccumulative and the criteria for 'B' or ‘vB’ is not fulfilled.

 

T Properties

The substance is not classified with respect to carcinogenicity, mutagenicity, reproductive toxicity and there is no evidence of chronic toxicity.  Therefore, the test material is not considered T.

 

 

The 72-hour EL10 in freshwater algae is considered to be 2.89 mg/L. Therefore, the chronic data would not support an assessment of T.The 72-hour EL50 in freshwater algae is considered to be >100 mg/L. The substance is, therefore, considered not toxic to algae. The 96 -hour LL50 in freshwater fish is considered to be >100 mg/L. The substance is, therefore, considered not toxic to freshwater fish species. The 48 -hour EL50 in freshwater Daphnia is considered to be >100 mg/L. The substance is, therefore, considered not toxic to Daphnia magna. As there is no evidence from short-term studies in crustaceans or fish to indicate that they are more sensitive to the test substance than algae, the aquatic toxicity data would not support an assessment of T. All of the study data available to assess the genetic toxicity of the substance in vitro and in vivo indicate a lack of response, achieving negative responses at all endpoints. The data available to assess reproduction toxicity also demonstrate a lack of response to parent and F1 animals with no effects on reproduction. On the basis of the genetic and reproduction toxicity data available, in addition to the repeated dose toxicity data the substance is considered to not present the potential for carcinogenic hazard. No additional data are therefore proposed and the substance is not classified for this endpoint. The repeated dose toxicity of the test material to rats was investigated in accordance with the standardised guideline OECD 422, under GLP conditions. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). The test material was administered by gavage to three groups each of ten male and ten female rats, for up to fifty-four consecutive days (including a two week maturation phase, pairing, gestation and early lactation for females), at dose levels of 750, 200 and 50 mg/kg/day. A control group of ten males and ten females was dosed with vehicle alone (arachis oil). Under the conditions of this study the no observable adverse effect level (NOAEL) for animals of either sex was considered to be 750 mg/kg/day. In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to repeated dose toxicity, specifically in relation to specific target organ toxicity - repeated exposure.